FDA.reportPublic FDA data

La Roche Posay Laboratoire Dermatologique Anthelios 30 Cooling Water Broad Spectrum SPF 30 Sunscreen

Product NDC
49967-392
11-digit product format
499670392
Labeler code
49967
Product ID
49967-392_be2582cd-fb64-42ff-bc23-f9e2753e48bc
Type
HUMAN OTC DRUG
Nonproprietary name
Avobenzone, Homosalate, Octisalate, Octocrylene and Oxybenzone
Dosage form
LOTION
Route
TOPICAL
Labeler
L'Oreal USA Products Inc
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-02-01
Substance
AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE
Active strength
22.4; 80; 24; 44.8; 28.8 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
La Roche Posay Laboratoire Dermatologique Anthelios 30 Cooling Water Broad Spectrum SPF 30 Sunscreen
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AVOBENZONE22.4 mg/mL
HOMOSALATE80 mg/mL
OCTISALATE24 mg/mL
OCTOCRYLENE44.8 mg/mL
OXYBENZONE28.8 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 5 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
G63QQF2NOXInternal UNII lookup
V06SV4M95SInternal UNII lookup
4X49Y0596WInternal UNII lookup
5A68WGF6WMInternal UNII lookup
95OOS7VE0YInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
d7bf3928-85b8-4e5f-a04a-d520130a3340Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49967-392-01La Roche Posay Laboratoire Dermatologique Anthelios 30 Cooling Water Broad Spectrum SPF 30 Sunscreen150 mL in 1 TUBELOTION1504
49967-392-02La Roche Posay Laboratoire Dermatologique Anthelios 30 Cooling Water Broad Spectrum SPF 30 Sunscreen5 mL in 1 TUBELOTION54

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AVOBENZONEACTIVE INGREDIENTG63QQF2NOXLA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE ANTHELIOS 30 COOLING WATER BROAD SPECTRUM SPF 30 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONE) LOTION [L'OREAL USA PRODUCTS INC]1
HOMOSALATEACTIVE INGREDIENTV06SV4M95SLA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE ANTHELIOS 30 COOLING WATER BROAD SPECTRUM SPF 30 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONE) LOTION [L'OREAL USA PRODUCTS INC]1
OCTISALATEACTIVE INGREDIENT4X49Y0596WLA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE ANTHELIOS 30 COOLING WATER BROAD SPECTRUM SPF 30 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONE) LOTION [L'OREAL USA PRODUCTS INC]1
OCTOCRYLENEACTIVE INGREDIENT5A68WGF6WMLA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE ANTHELIOS 30 COOLING WATER BROAD SPECTRUM SPF 30 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONE) LOTION [L'OREAL USA PRODUCTS INC]1
OXYBENZONEACTIVE INGREDIENT95OOS7VE0YLA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE ANTHELIOS 30 COOLING WATER BROAD SPECTRUM SPF 30 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONE) LOTION [L'OREAL USA PRODUCTS INC]1
AVOBENZONEACTIVE MOIETYG63QQF2NOXLA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE ANTHELIOS 30 COOLING WATER BROAD SPECTRUM SPF 30 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONE) LOTION [L'OREAL USA PRODUCTS INC]1
HOMOSALATEACTIVE MOIETYV06SV4M95SLA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE ANTHELIOS 30 COOLING WATER BROAD SPECTRUM SPF 30 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONE) LOTION [L'OREAL USA PRODUCTS INC]1
OCTISALATEACTIVE MOIETY4X49Y0596WLA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE ANTHELIOS 30 COOLING WATER BROAD SPECTRUM SPF 30 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONE) LOTION [L'OREAL USA PRODUCTS INC]1
OCTOCRYLENEACTIVE MOIETY5A68WGF6WMLA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE ANTHELIOS 30 COOLING WATER BROAD SPECTRUM SPF 30 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONE) LOTION [L'OREAL USA PRODUCTS INC]1
OXYBENZONEACTIVE MOIETY95OOS7VE0YLA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE ANTHELIOS 30 COOLING WATER BROAD SPECTRUM SPF 30 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONE) LOTION [L'OREAL USA PRODUCTS INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49967-392LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE ANTHELIOS 30 COOLING WATER BROAD SPECTRUM SPF 30 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONE) LOTION [L'OREAL USA PRODUCTS INC]4Current NDC, Legacy NDC, 2 package rows20240101_d7bf3928-85b8-4e5f-a04a-d520130a3340.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 118 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Eclipse Face TintedZINC OXIDEDENISE BELL SKIN CARE396f0151-2d0d-f4da-e063-6394a90a5f7f2025-12-15Exact identifier
application number: M020
Eclipse Body Non TintedZINC OXIDEDENISE BELL SKIN CARE396f56df-d0de-1344-e063-6294a90a46ea2025-12-15Exact identifier
application number: M020
Solar Shield TintedTITANIUM DIOXIDE, ZINC OXIDEDENISE BELL SKIN CARE396eb781-5947-3665-e063-6294a90a38dd2025-12-15Exact identifier
application number: M020
Sun Veil Illuminating Sunscreen SPF30ZINC OXIDEKoco Life LLC46001097-540e-65da-e063-6294a90af2992025-12-15WarningsExact identifier
application number: M020
Mineral Primer tinted SPF40TITANIUM DIOXIDE, ZINC OXIDEOracle Esthetics, LLC3542d8d3-35a3-7d63-e063-6394a90a6fd12025-12-15Exact identifier
application number: M020
Mineral Primer non-tinted SPF40TITANIUM DIOXIDE, ZINC OXIDEOracle Esthetics, LLC354357de-1a85-3bdb-e063-6294a90aa9a22025-12-15Exact identifier
application number: M020
Mineral Primer tinted SPF40TITANIUM DIOXIDE, ZINC OXIDEOracle Esthetics, LLC35433254-1dc8-a8f3-e063-6394a90a29f02025-12-15Exact identifier
application number: M020
Sun Therapy SunscreenZINC OXIDESkin Therapy Studio LLC3544916b-3f63-3a7a-e063-6394a90ae5072025-12-15Exact identifier
application number: M020
Ultra Zinc Mineral Non TintedZINC OXIDESkin Therapy Studio LLC3545d603-3d01-c51d-e063-6394a90a15992025-12-15Exact identifier
application number: M020
Sun Therapy SunscreenZINC OXIDESkin Therapy Studio LLC357efafb-aa1c-0d69-e063-6394a90a51352025-12-15Exact identifier
application number: M020
Ultra Zinc Mineral Non TintedZINC OXIDESkin Therapy Studio LLC35806102-6919-116f-e063-6294a90ad9222025-12-15Exact identifier
application number: M020
Complexion Correction Primer Sunscreen clearTITANIUM DIOXIDE, ZINC OXIDEMCRAE MD MEDICAL LASER CENTER, A TEXAS PROFESSIONAL LIMITED LIABILITY COMPANY357eee3c-1c21-5efb-e063-6294a90a4bb72025-12-15Exact identifier
application number: M020
Complexion Correction Tinted Primer SunscreenTITANIUM DIOXIDE, ZINC OXIDEMCRAE MD MEDICAL LASER CENTER, A TEXAS PROFESSIONAL LIMITED LIABILITY COMPANY357e75ec-473e-df76-e063-6294a90a70c72025-12-15Exact identifier
application number: M020
Complexion Correction Tinted Primer SunscreenTITANIUM DIOXIDE, ZINC OXIDEMCRAE MD MEDICAL LASER CENTER, A TEXAS PROFESSIONAL LIMITED LIABILITY COMPANY357f2f62-904a-2234-e063-6394a90aee722025-12-15Exact identifier
application number: M020
Superscreen Daytime Mineral SunscreenZINC OXIDEMCRAE MD MEDICAL LASER CENTER, A TEXAS PROFESSIONAL LIMITED LIABILITY COMPANY357f915a-bd77-350b-e063-6294a90ad27f2025-12-15Exact identifier
application number: M020
Complexion Correction Primer Sunscreen clearTITANIUM DIOXIDE, ZINC OXIDEMCRAE MD MEDICAL LASER CENTER, A TEXAS PROFESSIONAL LIMITED LIABILITY COMPANY357ff025-84ad-6d77-e063-6394a90aad952025-12-15Exact identifier
application number: M020
Complexion Correction Tinted Primer SunscreenTITANIUM DIOXIDE, ZINC OXIDEMCRAE MD MEDICAL LASER CENTER, A TEXAS PROFESSIONAL LIMITED LIABILITY COMPANY358021a2-235b-825b-e063-6394a90a76f52025-12-15Exact identifier
application number: M020
Superscreen Daytime Mineral SunscreenZINC OXIDEMCRAE MD MEDICAL LASER CENTER, A TEXAS PROFESSIONAL LIMITED LIABILITY COMPANY35805e66-18e6-0e45-e063-6294a90afe582025-12-15Exact identifier
application number: M020
Ultra Zinc Physical DefenseZINC OXIDEATLANTA DERMOTOLOGY VEIN & RESEARCH CENTER35474ac4-8a9d-6a84-e063-6394a90a9bad2025-12-15Exact identifier
application number: M020
Ultra Zinc Physical DefenseZINC OXIDEATLANTA DERMOTOLOGY VEIN & RESEARCH CENTER357e315e-8802-ad73-e063-6394a90a24952025-12-15Exact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49967-392-0149967039201150 mL in 1 TUBE (49967-392-01) 150 ml2014-02-010000-00-00NoNoCurrent
49967-392-02499670392025 mL in 1 TUBE (49967-392-02) 5 ml2014-02-010000-00-00NoNoCurrent